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Special Drug Use Investigation for PAXIL (Paroxetine) Social Anxiety Disorder (Long-term)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01376271
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : July 2, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The study is designed to evaluate the safety and efficacy of paroxetine on the long-term use in Japanese Social Anxiety Disorder (SAD) subjects.

Condition or disease Intervention/treatment
Social Phobia Drug: Paroxetine

Study Design

Study Type : Observational
Actual Enrollment : 600 participants
Official Title: Special Drug Use Investigation for PAXIL (Paroxetine) Social Anxiety Disorder (Long-term)
Study Start Date : January 2010
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Subjects prescribed paroxetine tablets
Subjects with SAD prescribed paroxetine tablets during study period
Drug: Paroxetine


Outcome Measures

Primary Outcome Measures :
  1. The number of adverse events in Japanese subjects with social anxiety disorder treated with paroxetine tablets [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All subjects diagnosed as having social anxiety disorder (SAD) are to be given paroxetine tablets according to the prescribing information
Criteria

Inclusion Criteria:

  • Subjects who are diagnosed as having SAD
  • Subjects who are expected to use paroxetine tablets for the first time

Exclusion Criteria:

  • Subjects taking pimozide
  • Subjects taking monoamine oxidase (MAO) inhibitor or within two weeks after discontinuation of MAO inhibitor
  • Subjects with hypersensitivity to paroxetine
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376271


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01376271     History of Changes
Other Study ID Numbers: 114102
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: July 2, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors